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A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)

NCT05814159 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-05

No results posted yet for this study

Summary

A study to demonstrate efficacy and safety of anakinra in pediatric and adult Japanese patients with Still's disease (Systemic juvenile idiopathic arthritis \[SJIA\] and Adult-onset Still's disease \[AOSD\]).

Conditions

  • Still's Disease, Juvenile Onset
  • Still's Disease, Adult-Onset

Interventions

DRUG

Anakinra

sub cutaneous daily injection

DRUG

Placebo

sub cutaneous daily injection

Sponsors & Collaborators

  • CMIC Co, Ltd. Japan

    collaborator INDUSTRY

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Masaaki Mori, MD · St. Marianna University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2025-12-10
Completion
2026-06-24
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05814159 on ClinicalTrials.gov